Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 884 - Obstetrical and Gynecological Devices |
Subpart D - Obstetrical and Gynecological Prosthetic Devices |
§ 884.3200 - Cervical drain.
Latest version.
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§ 884.3200 Cervical drain.
(a) Identification. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.
(b) Classification. Class II (performance standards). special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]